Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

Recruiting

• Conditions: SSNHL(Sudden Sensory Neural Hearing Loss); Sudden Hearing Loss; Hearing Loss, Idiopathic Sudden Sensorineural; Hearing Loss, Sudden

• Registration Number: NCT05474963
• Lead Sponsor: Wonju Severance Christian Hospital

Brief Summary

This study is to build a cohort of sudden sensorineural hearing loss (SSNHL) patients. When the patient visited the Department of otolaryngology clinic for hearing loss, we can diagnose the SSNHL following the result of pure tone audiometry and the history of the patient. The cohort is a system that tracks the hearing recovery status, timing, and degree of recovery of patients who received cocktail therapy with or without high-dose steroids, vasodilators, antiviral agents, and intratympanic steroid injections, satellite ganglion block, and hyperbaric oxygen therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2031-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adult patients over 20 years of age
• A patient who visited Wonju Severance Christian Hospital, Department of Otolaryngology and was diagnosed with sudden hearing loss as it was confirmed that hearing loss of 30dBHL or more occurred within 3 days at three consecutive frequencies in a pure tone audiometry test.
• Those who have fully explained the purpose and content of the study and voluntarily agreed to the written consent

Exclusion Criteria

• If the patients do not want to or do not fill out the consent form
• If treatment is started for sudden hearing loss, but the possibility of other inner ear diseases including Meniere's disease is suspected due to repeated hearing loss, repeated recovery, dizziness, tinnitus, etc.
• Other cases where it is judged difficult to carry out the clinical trial due to the judgment of the person in charge of the above clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing outcome 1 week - PTA	1 week PTA	Hearing change status near 1 weak after treatment start measured by pure tone audiometry1
Hearing outcome 3 weeks - PTA	3 weeks PTA	Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
Hearing outcome 3 months - PTA	3 month PTA	Hearing change status near 3 months after treatment start measured by pure tone audiometry
Hearing outcome 6 months - PTA	6 months PTA	Hearing change status near 6 months after treatment start measured by pure tone audiometry, which is final.
Hearing outcome 2 months - PTA	2 month PTA	Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

Secondary Outcome Measures

Name	Time	Method
Electrolytes and chemistries after high dose steroid therapy	5 days electrolytes and chemistries	The results of blood tests of electrolytes and chemistries at 5 days after treatment start.; (Na, K, Cl, CO2, BUN, Cr, Glucose, Amylase, Total protein, Albumin, AST, ALT, ALP, r-GT, Total Bilirubin)

Trial Locations

Locations (1)

Yonsei University Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwon, Korea, Republic of